Link Hepatitis C Notifications to Treatment in Tasmania

Hepatitis C Clinical Trial

Official title:

A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510246
• Other study ID #: Tas RCT HCV Notifications
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: February 2022
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: Joseph Doyle, PhD
• Phone: +613 9076 5436
• Email: joseph.doyle[@]burnet.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will utilise the notification process as a point of intervention to work with primary practitioners (GP) by contacting them directly when a notification of hepatitis C exposure is received by the Tasmanian department of Health (DoH). A designated role will exist within DoH of a specialist HCV health worker to contact GPs to provide supported assistance in the process of the follow up hepatitis C diagnoses with patients. The study will evaluate whether active follow up of providers with enhanced case management is effective in having patients linked to hepatitis C treatment compared to current standard of care of surveillance for new notifications. The study will also compare the cost-effectiveness of this approach compared to current standard of care after one of their patients is notified with a positive hepatitis C antibody result.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health

Exclusion Criteria:

• Not based in Tasmania
• Practitioner from correctional service
• Specialist
• Nurse practitioner who initiated test
• Sexual health service doctor
• Family planning
• Trainee

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• Enhanced case management
The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including: Further testing advice Awareness that treatment can be prescribed by the general practitioner Conducting pre-treatment work-up assessment DAA prescription guidelines, including linkage to specialist consultation Providing treatment support Advising on testing process for cure Advising on post-cure management including methods of follow-up to manage risks (e.g. harm minimisation, reducing re-infection risk, opioid substitution therapy) Linking GP to resources for patients with cirrhosis or other concerns to specialist support for ongoing management. The GP will be offered the option of the DoH specialist to contact the patient directly with the GP's consent to notify them of their result and to educate them on testing and treatment options and referral back to their GP.

Locations

Country	Name	City	State
Australia	Tasmanian Department of Health	Hobart	Tasmania

Sponsors (2)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	Department of Health and Human Services

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cases notified with hepatitis C who commence hepatitis C treatment	The primary outcome will be the proportion of cases notified with hepatitis C who commence hepatitis C treatment within 12 weeks of initial contact. This will be assessed using the information provided by practitioners at the 12-week follow-up phone call and will be compared across the two arms.	The study follow up period is 12 weeks
Secondary	Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result	The the proportion of cases notified with hepatitis C with documented HCV RNA results within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners.	The study follow up period is 12 weeks
Secondary	Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests	The the proportion of HCV RNA positive cases who completed treatment work up blood tests within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners.	The study follow up period is 12 weeks
Secondary	Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed	The the proportion of HCV cases who complete an appropriate course of prescribed hepatitis C treatment..	The study follow up period is 12 weeks